ANCURE ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS

FDA premarket approval P990017/S011 · decided 2001-09-20

Approval details

PMA number

P990017

Supplement

S011

Supplement type

Normal 180 Day Track

Supplement reason

Postapproval Study Protocol

Trade name

ANCURE ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

Boston Scientific Corp

Date received

2000-09-25

Decision date

2001-09-20

Days to decision

360 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

APPROVAL FOR MODIFICATIONS TO THE FIVE YEAR FOLLOW-UP PROTOCOL: A) CHANGING THE FOLLOW-UP SCHEDULE; B) REMOVING THE ULTRASOUND AND ANKLE BRACHIAL INDICES (ABI) ASSESSMENTS; C) REPLACING THE ANNUAL PHYSICAL EXAM FOR CONTROL PATIENTS WITH AN ANNUAL TELEPHONE SURVEY AND COMPUTED TOMOGRAPHY (CT) AND PHYSICAL EXAM AT THE FIVE YEAR MARK; D) ALLOWING AN OPTIONAL TELEPHONE SURVEY FOR PATIENTS UNABLE OR UNWILLING TO COME TO THE INVESTIGATIONAL SITE; AND E) EXCLUDING PATIENTS WHO HAVE BEEN CONVERTED FROM

510(k) clearances by this applicant